Approval for an alternate raw material source.
| Device | ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2004-02-27 |
| Decision Date | 2004-08-06 |
| PMA | P030019 |
| Supplement | S001 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030019 | | Original Filing |
| S027 |
2022-10-12 |
30-day Notice |
| S026 |
2020-12-30 |
135 Review Track For 30-day Notice |
| S025 |
2020-11-09 |
30-day Notice |
| S024 | | |
| S023 |
2016-02-10 |
Special (immediate Track) |
| S022 |
2014-12-24 |
135 Review Track For 30-day Notice |
| S021 |
2014-06-25 |
30-day Notice |
| S020 |
2014-06-10 |
30-day Notice |
| S019 |
2014-05-15 |
30-day Notice |
| S018 |
2011-08-24 |
135 Review Track For 30-day Notice |
| S017 |
2010-11-03 |
135 Review Track For 30-day Notice |
| S016 | | |
| S015 |
2010-06-09 |
30-day Notice |
| S014 |
2009-06-16 |
Normal 180 Day Track No User Fee |
| S013 |
2006-07-24 |
135 Review Track For 30-day Notice |
| S012 |
2006-08-09 |
Normal 180 Day Track |
| S011 | | |
| S010 |
2006-07-10 |
30-day Notice |
| S009 |
2006-04-28 |
Normal 180 Day Track |
| S008 |
2006-01-03 |
30-day Notice |
| S007 | | |
| S006 |
2004-07-01 |
Normal 180 Day Track |
| S005 |
2004-06-17 |
30-day Notice |
| S004 |
2004-05-07 |
30-day Notice |
| S003 |
2004-03-16 |
30-day Notice |
| S002 | | |
| S001 |
2004-02-27 |
135 Review Track For 30-day Notice |
NIH GUDID Devices